DYNAMIC PRICING OF THE PROTEIN KINASE INHIBITOR CLASS: A RETROSPECTIVE INTERNATIONAL ANALYSIS
Author(s)
Solal Saied, MS (Pending), PharmD (Pending)1, AMINE AISSAOUI, MS, PharmD, PhD2.
1Student, Dauphine-PSL University & University of Paris, Paris, France, 2Dauphine-PSL University, Paris, France.
1Student, Dauphine-PSL University & University of Paris, Paris, France, 2Dauphine-PSL University, Paris, France.
OBJECTIVES: Protein kinase inhibitors (PKIs) constitute an expanding class of small-molecule drugs, marketed since 1999 and initially developed in oncology before extending to non-neoplastic indications. This study investigates whether the pricing and reimbursement landscape of PKIs and its evolution can be explained through several dimensions: pharmacological target, the neoplastic versus non-neoplastic nature of indications, time since authorisation, and the market considered.
METHODS: A retrospective database was constructed with regulatory data on marketing authorisations and indications, published by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), with national pricing and reimbursement data from the five markets studied. The study covers all PKIs marketed between 1999 and 2026, totalling 94 molecules. For each molecule, the database compiles the annual list price (as of June 2026) across five major markets (United States, France, Germany, United Kingdom, China), all EMA and FDA registered indications, the years of first marketing authorisation, the pharmacological target, and the neoplastic status. Molecules were grouped into pharmacological target clusters and analysed descriptively.
RESULTS: Mean annual list prices differed markedly across markets and indication status, with the United States consistently the highest-priced market. For neoplastic PKIs, the US mean was approximately USD 317,700; list prices were 65% lower in Europe and 78% lower in China. For non-neoplastic PKIs, the US mean was approximately USD 102,900; list prices were about 61% lower in Europe and 84% lower in China. These cross-market price differentials, observed before confidential rebates and HTA-negotiated discounts, were compounded by within-market variation according to pharmacological target classification, suggesting a "class-based" facial pricing logic.
CONCLUSIONS: These preliminary results reveal distinct pricing dynamics across markets and according to molecule status, indication type and pharmacological class. They support a multidimensional reading of PKI pricing and value assessment, with implications for HTA and market-access strategies across jurisdictions.
METHODS: A retrospective database was constructed with regulatory data on marketing authorisations and indications, published by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), with national pricing and reimbursement data from the five markets studied. The study covers all PKIs marketed between 1999 and 2026, totalling 94 molecules. For each molecule, the database compiles the annual list price (as of June 2026) across five major markets (United States, France, Germany, United Kingdom, China), all EMA and FDA registered indications, the years of first marketing authorisation, the pharmacological target, and the neoplastic status. Molecules were grouped into pharmacological target clusters and analysed descriptively.
RESULTS: Mean annual list prices differed markedly across markets and indication status, with the United States consistently the highest-priced market. For neoplastic PKIs, the US mean was approximately USD 317,700; list prices were 65% lower in Europe and 78% lower in China. For non-neoplastic PKIs, the US mean was approximately USD 102,900; list prices were about 61% lower in Europe and 84% lower in China. These cross-market price differentials, observed before confidential rebates and HTA-negotiated discounts, were compounded by within-market variation according to pharmacological target classification, suggesting a "class-based" facial pricing logic.
CONCLUSIONS: These preliminary results reveal distinct pricing dynamics across markets and according to molecule status, indication type and pharmacological class. They support a multidimensional reading of PKI pricing and value assessment, with implications for HTA and market-access strategies across jurisdictions.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HTA170
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Systems & Structure
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, Oncology